Concurrent treatment of oral and systemic maladies using direct current electricity

ABSTRACT

A method and apparatus for the concurrent treatment of multiple oral diseases and defects while promoting general oral hygiene utilizing electricity are provided for non-human animals. Electrodes are used to deliver an electrical current to the gingival tissues of a mouth in order to achieve a number of therapeutic, prophylactic, and regenerative benefits. These benefits include killing oral microbes, increasing oral vasodilation, reducing oral biofilm, improving oral blood circulation, reversing oral bone resorption, promoting oral osteogenesis, treating gum recession, and fostering gingival regeneration. Other benefits include the treatment of gingivitis, periodontitis, and oral malodor, and other systemic diseases correlated with oral pathogens.

RELATED APPLICATIONS

This application is a continuation of U.S. patent application Ser. No.14/102,171, filed Dec. 10, 2013, now U.S. Pat. No. 9,314,321, andentitled “Concurrent Treatment Of Oral And Systemic Maladies In AnimalsUsing Electrical Current,” which is a continuation-in-part of U.S.patent application Ser. No. 13/839,513, filed Mar. 15, 2013, now U.S.Pat. No. 9,168,370, and entitled “Concurrent Treatment Of Oral AndSystemic Maladies Using Direct Current Electricity,” which is acontinuation-in-part of U.S. patent application Ser. No. 12/205,062filed Sep. 5, 2008, now U.S. Pat. No. 8,660,669, and entitled“Concurrent Treatment of Oral Maladies Using Direct CurrentElectricity,” which is a continuation-in-part of U.S. Ser. No.11/850,661 filed on Sep. 5, 2007, now abandoned, and entitled “HygieneMouthpiece,” all of which are incorporated by reference herein in theirentireties.

BACKGROUND

This invention relates to a method of concurrently promoting generaloral hygiene, treating periodontal diseases such as gingivitis andperiodontitis, killing oral microbes including cavity-causing bacteria,reducing oral biofilms, increasing blood flow in oral tissues,increasing salivation, promoting gingival tissue regeneration, fosteringosteogenesis in the boney structures of the teeth, mouth and relatedareas, treating systemic diseases associated with oral bacteria, andtreating other periodontal and oral maladies through the non-invasiveapplication of weak direct current electricity to the surfaces in theoral cavity, and it also relates to an apparatus suitable for providingdirect current electricity for these therapeutic, prophylactic, andregenerative effects.

Periodontal disease has been identified as a risk factor for varioussystemic diseases by both dentists and physicians. Included in thesediseases are cardiovascular disease, adverse pregnancy outcomes, anddiabetes with newfound evidence supporting its association withpancreatic diseases and arthritis. While many of the studies establishcorrelation between the presence of periodontal disease and thesesystemic conditions, causation, with most of these conditions, is stilla subject of ongoing research. A few of the biological mechanisms whichhave been proposed as to how oral bacteria stemming from periodontaldisease can cause systemic disease are as followed:

1. Direct effect of oral infections: Oral microbes and their byproductscan gain systemic access via the circulatory system through travelingthrough compromised tissue and inflamed periodontium in the oral cavity.In gaining systemic access, oral microbes have the potential to directlyinfluence subclinical mediators of various systemic diseases.

2. Inflammation: People with periodontal disease have elevated levels ofsystemic inflammatory markers due to the burden of increased levels oforal bacteria. Treatment for periodontal disease has been reported todecrease systemic inflammation levels.

3. Cross-reactivity: The progression of systemic diseases can beaccelerated by the immune response to bacterial heat-shock proteinscreating antibodies that cross-react with innate heat shock proteinsexpressed on cells of the damaged tissues.

Cardiovascular Disease

Studies investigating the potential association between periodontaldisease and cardiovascular diseases, including atherosclerosis, coronaryheart disease, and stroke have found a significant positive correlationbetween poor oral health and the prevalence of cardiovascular disease.While both diseases share several common risk factors, recent studiessuggest that periodontitis may precede and therefore contribute toatherosclerotic complications. In fact, meta-analyses show that subjectssuffering from periodontitis experience an increased risk for developingcardiovascular diseases.

While it has not been definitively shown if these bacteria initiateatherosclerosis or rather invade an already compromised artery,antibodies to periodontal bacteria, including Fuseobacterium nucleatumand Streptococcus oralis, have been found in blood serum and areassociated with an increased risk of coronary heart disease. A mousestudy found that intravenous inoculation with Porphyromonas gingivalisaccelerated atherosclerotic development. Further, following oralinoculation, P. gingivalis DNA was found in the aortic tissue of thoseinfected mice that showed observable signs of accelerated earlyatherosclerosis. Another study has named F. nucleatum as a synergisticagent with P. gingivalis. F. nucleatum enhances the ability of P.gingivalis to invade host cells due to a coaggregating effect betweenthe two organisms. This is significant as bacteria within the atheromamay lead to the development of atherosclerotic plaque. The evidence thusfar supports the idea that periodontitis leads to systemic exposure tooral bacteria which serves as a potential source of systemicinflammatory mediators, cytokines produced in the infected periodontaltissues, capable of initiating or worsening atherosclerosis and coronaryheart disease when they enter into the blood stream. Clinical studies onperiodontal disease have also revealed a positive association withcoronary disease and emphasis is now being placed on understanding theexact relation between periodontal disease and atherosclerosis.

Pre-Term Birth

Fusobaceterium nucleatum, one of the most prevalent species of bacteriafound in amniotic fluid and placental infections that cause pretermbirth, is also often named the sole infectious agent in preterm laborwith intact fetal membranes. F. nucleatum is also highly associated withvarious types of periodontal disease. During periodontal infection, whenthe oral mucosa is injured and inflamed and the quantities ofperiodontal pathogens increase dramatically, transient levels ofbacteria can appear in the blood leading to selective colonization ofundesired sites. One study demonstrated that pregnant mice injectedhematogenously with F. nucleatum isolated from either amniotic fluidinfection or an oral source resulted in fetal death.

Recently, a human stillbirth case was analyzed and it was found that theF. nucleatum did indeed originate from the mother's oral cavity, a factthat had not yet been proven. It is likely that the F. nucleatumtranslocated from the mother's mouth via the blood stream where it wasthen able to cross the endothelium to proliferate and colonize withinthe fetal membranes, amniotic fluid and fetus whereupon its presencelead to fetal demise. In a mouse model, hematogenous injection of F.nucleatum into pregnant mice resulted in specific bacterial colonizationin the placenta causing localized inflammation. F. nucleatum wascompletely cleared from the maternal circulation after 24 hours ofinjection. However, once colonized in the immune privileged placenta,the bacteria proliferated quickly and caused fetal death within 3 days.Chronic periodontal disease could mediate infection through thetranslocation of periodontal bacteria/inflammatory markers to thefetoplacental unit.

Diabetes

Diabetes mellitus is an endocrine disease that stems from genetic,environmental and behavioral risk factors. For the past several decades,diabetes has been considered a modifying factor for periodontal diseasewith recent years suggesting a bidirectional relationship between thetwo. Further, presence of periodontal disease has been implicated as arisk for diabetic complications, namely poor glycemic control. Recentlongitudinal and systemic studies have seen periodontal diseasecorrelated to higher risks of death from ischemic heart disease,diabetic nephropathy, end-stage renal disease and increased insulinresistance compared to patients with mild or no periodontal disease. Intype II diabetes, insulin resistance is linked to the actions ofpro-inflammatory cytokines. It is believed that periodontal diseaseleads to a significantly higher amount of these serum markers ofinflammation, thus conferring insulin resistance. A human studyexamining the bacterial content of adults with and without type IIdiabetes found diabetic patients had significantly more severeperiodontitis and higher levels of many oral bacteria, includingStreptococcus oralis.

Pyogenic Liver Abscess

F. nucleatum has recently been implicated in pyogenic liver abscess(PLA). Normally caused by biliary tract pathology, diverticular diseaseand bowel malignancy, atrophic gastritis and cryptogenic liver disease,PLA caused by F. nucleatum is very rare with Escherichia coli,Klebsiella and Enterobacter being the most commonly isolatedmicroorganisms in the drained abscesses. F. nucleatum was found in theliver abscess with no other infectious source being found, except for adental extraction. It is hypothesized that due to the coaggregationproperties of F. nucleatum, it is able to transport and breach themucosa of the colon and lead to bacteremia which results in hepaticabscess.

Osteomyelitis

Osteomyelitis is a bone infection caused by bacteria, fungi or othergerms. Commonly, bacteria spreads to the bone from infected skin,muscles or tendons and often time occur under a skin sore. The infectioncan also start in another part of the body and spread hematogenously.Occasionally Fusobacterium species have been isolated from bone/jointinfections in the head and neck area and were associated with chronicperiodontitis. A recent study has reported a case of osteomyelitiscaused by F. nucleatum in conjunction with muscle abscess. The patienthad no known predisposing factors and had no other infection sourcesexcept a history of periodontal disease. It is believed that due to thepatient's poor oral hygiene, F. nucleatum bacteremia may have developedand lead to a hematogenous osteomyelitis of the lower leg.

Arthritis

Numerous clinical studies have suggested a potential association betweenrheumatoid arthritis (RA) and periodontal disease as several oralbacteria species, such as P. gingivalis and Prevotella intermedia, havebeen isolated from the synovial fluid of patients. Periodontal diseaseis thought to allow bacteria to penetrate through the permeable pocketepithelial in the oral cavity to reach the underlying gingivalconnection tissue. From there, it may be transported out into thebloodstream with the ability to colonize elsewhere within the body. Theoral bacteria found in the synovial fluid of patients suffering from RAhas been attributed to synovial inflammation favorably trapping oralbacteria DNA, which suggests periodontal disease may have a perpetuatingeffect on joint diseases. Therefore, periodontitis may in fact be afactor leading to the autoimmune inflammatory responses characteristicof RA. Patients suffering from RA may also be at a higher risk ofdeveloping periodontal disease thus suggesting a bidirectionalrelationship between the two conditions. One particular study examinedthe presence of bacterial DNA in the synovial fluids of native andfailed prosthetic joints of patients suffering from arthritis. Out ofthe 5 patients where bacterial DNA was found, F. nucleatum was detectedin 4 of these 5 patients. This suggests that this bacterium cantranslocate from the oral cavity to the synovial fluid, as F. nucleatumwas also found in the patient's plaque sample.

Oral Biofilm

Periodontitis, gingivitis, and caries are infectious diseases of theoral cavity in which oral biofilm plays a causative role. Biofilmformation is also involved in the pathogenesis of dental implantfailures such as peri-implantitis, denture stomatitis, and oral yeastinfections such as candidiasis. Oral biofilms begin with dental pellicleformation on the teeth. This pellicle is composed of salivary proteinsthat coat the exposed surfaces of the teeth, primarily thesupra-gingival ones, to which the planktonic bacteria begin to adhere.The aerobic bacteria, including gram-positive cocci, such as S. oralis,are the early colonizers that begin forming the initial biofilm colony,primarily through cellular division of the adherent bacteria.

Once the initial colony has been established, other co-aggregatingbacteria species, such as F. nucleatum, P. gingivalis, and othergram-negative, anaerobic bacteria attach to the previously formedcolonies. As these colonies mature, they grow to cover the sub-gingivalsurfaces of the teeth and begin to induce inflammation in theperiodontium.

SUMMARY OF THE INVENTION

The present invention relates to a method and apparatus for aidingoverall oral health of a non-human animal, and more particularly totreating periodontal diseases such as gingivitis and periodontitis,killing oral microbes including cavity-causing bacteria, reducing oralbiofilms, increasing blood flow in oral tissues, increasing salivation,promoting gingival tissue regeneration, fostering osteogenesis in theboney structures of the teeth, mouth and related areas, treatingsystemic diseases associated with oral bacteria, and treating otherperiodontal and oral maladies through the non-invasive application ofweak direct current electricity to the surfaces in the oral cavity.

One aspect of the present invention is to provide a method comprisingthe steps of providing a treatment apparatus and making the treatmentapparatus accessible to a non-human animal. The treatment apparatusincludes an electrical power source and a plurality of electricallyconductive surfaces (which may include an electrically conductivepolymer and/or fabric) on an external surface of the apparatus. Thetreatment device is provided to the animal to be drawn at leastpartially into its mouth and in contact with an oral secretion ortissue, such as at least one of saliva, lingual tissue, dental tissue,gingival tissue, periodontal tissue, and oral mucosa tissue. The oralsecretion and/or tissue provides an electrically conductive path betweenat least two of the conductive surfaces and electrical current isdelivered to the electrically conductive path by at least one of theconductive surfaces.

According to another aspect of a method according to the presentinvention, the treatment apparatus may regulate the current that isdelivered, such as from about 50 microamps to about 500 microamps.

According to still another aspect of a method according to the presentinvention, the electrical current delivered to the oral secretion ortissue reduces the amount of oral biofilm and/or viable oral bacteria inthe mouth of the animal. Such reduction may prevent, treat, and/ormitigate systemic disease in the animal. Types of oral bacteria, amountsof which may be reduced by systems and methods according to the presentinvention, include one or more of P. gingivalis, C. rectus, A.actinomycetemcomitans, P. intermedia, T. forsythensis, F. nucleatum, E.corrodens, P. denticanis, P. gulae, P. salivosa, S. oralis, and T.denticola.

According to yet another aspect of a method according to the presentinvention, the method may further include the step of activating thetreatment apparatus, such as by operating an on/off switch, which may bea motion-activated switch (such as a reed switch in combination with amagnet) or a moisture-activated switch.

According to a further aspect of a method according to the presentinvention, the treatment apparatus may include a timer, which may ceasedelivery of electrical current or potential to the conductive surfaces,such as by disconnecting the power source from the conductive surfaces,after a predetermined time.

According to a still further aspect of a method according to the presentinvention, the method may comprise a step of diagnosing the animal witha disease, such as one or more of diabetes mellitus, kidney disease,cardiovascular disease, and periodontal disease. Where the disease isperiodontal disease, the animal may also have been diagnosed with one ormore of chronic bronchitis, pulmonary fibrosis, endocarditis,interstitial nephritis, glomerulonephritis, and hepatitis.

According to yet a further aspect of a system or method according to thepresent invention, the electrical current delivered by the treatmentapparatus may be direct current, which may be pulsed direct current.Additionally or alternatively, the treatment apparatus may be capable ofdelivering alternating current, which may be pulsed, and delivered at aconstant or variable frequency.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 demonstrates the overall structure of the first embodiment of adevice according to the present invention, including a microcontrolledpower source, user input, user feedback and oral electrodes.

FIG. 2 shows a top-down view of another embodiment that includes amouthpiece with two continuous electrodes and associated conductors.

FIG. 3 shows a perspective view of the same embodiment of FIG. 2, withtwo electrodes embedded in a mouthpiece.

FIG. 4 offers a top-down view of another embodiment similar to FIG. 2that includes a mouthpiece, but with a plurality of discrete electrodes.

FIG. 5 provides a perspective view of an additional embodiment similarto FIG. 4 with a plurality of electrodes that are electrically connectedby embedded conductors.

FIG. 6 shows an additional embodiment of a device according to thepresent invention with an analog power supply using a dual unit,three-port switch.

FIG. 7 is an exploded view of a first mold for molding a mouthpieceaccording to the present invention.

FIG. 8 is a cross sectional view of a first mold for molding amouthpiece according to the present invention.

FIG. 9 is an exploded view of a first mold for molding a mouthpieceaccording to the present invention with a partially molded mouthpiece.

FIG. 10 is an exploded view of a second mold for molding a mouthpieceaccording to the present invention with a partially molded mouthpiece.

FIG. 11 is perspective view of a second mold for molding a mouthpieceaccording to the present invention with a partially molded mouthpiece.

FIG. 12A is a cross section of the mold of

FIG. 11 with a partially molded mouthpiece in its unfilled state.

FIG. 12B is a cross section of the mold of FIG. 11 with a partiallymolded mouthpiece in its filled state.

FIG. 13 is a perspective view of a mouthpiece molded according to anembodiment of the present invention.

FIG. 14 is a perspective view of another embodiment of a deviceaccording to the present invention with an enclosed power supply.

FIG. 15 is a side view of the embodiment shown in FIG. 14.

FIG. 16 is a top view of the embodiment shown in FIG. 14.

FIG. 17A is a partially-exploded perspective view of the embodimentshown in FIG. 14.

FIG. 17B is a partial schematic cross-section taken along line 17B-17Bof FIG. 15.

FIG. 18 is a schematic illustrating an electrode arrangement accordingto the present invention.

DETAILED DESCRIPTION

Although the disclosure hereof is detailed and exact to enable thoseskilled in the art to practice the invention, the physical embodimentsherein disclosed merely exemplify the invention which may be embodied inother specific structures. While the preferred embodiment has beendescribed, the details may be changed without departing from theinvention, which is defined by the claims.

It is known in the art that oral bacteria cannot survive when exposed tolow-microampere direct current electricity. This method of killing oralbacteria and treating bacteria-caused conditions such as gingivitis hasbeen demonstrated in Nachman, U.S. Pat. No. 4,244,373 of Jan. 13, 1981and in Detsch, U.S. Pat. No. 4,509,519 of Apr. 9, 1985. Killing oralbacteria has the added benefit of preventing tooth decay and dentalcaries, or cavities. Generally, tooth decay is attributed to aerobicacid-producing bacteria whose acid causes uncompensated demineralizationof the teeth. However, Nachman does not instruct optimal approaches toreducing oral bacteria including aerobic and anaerobic bacteria on aspecies-by-species level and instead teaches a generic, untargetedtreatment.

While researching the effect of direct current electricity on the mouth,the applicants discovered that by increasing the current level to theapproximate range of 50 to 250 microamperes, a direct current electricaltreatment was able to deliver new and unexpected therapeutic,prophylactic, and regenerative benefits previously unknown in the art.

Specifically, by utilizing a direct current in the aforementioned range,not only did such a treatment kill bacteria, but it was also found tokill or disable viruses and fungus as well. Studies from the podiatricfield have shown that higher current levels than those used in existingoral electrical treatments are necessary to effectively treat fungalinfections (“Low-Voltage Direct Current as a Fungicidal Agent forTreating Onychomycosis”, Kalinowski, et al., Journal of the AmericanPodiatric Medical Association Vol. 94 No. 6: 565-572, 2004). By applyingthis knowledge of increased current levels from research outside theart, the applicants were able to add fungicidal and viricidal benefitsto a method already known to be bactericidal. The applicants' studieshave shown that these microbicidal properties begin to take effectwithin approximately 5 and 15 minutes of treatment, reducing both supra-and sub-gingival microbes.

In addition, the applicants' clinical research unexpectedly demonstratedthat a direct current in the approximate range of 50 to 250 microampereswas able to regenerate gingival tissues, providing a non-surgicaltreatment alternative for those with recessed gums. While the osteogenicproperties of electricity have been known in the art, the connectionbetween nonosseous tissue regeneration and electricity were not wellknown in the art prior to these experiments. The unique current rangeassociated with the method and apparatus of this invention is one of afew effective methods in the dental field to accomplish effectivegingival tissue regeneration in a non-surgical manner.

In further research, the applicants conducted preclinical testing thatexamined the effects of direct current stimulation on three differentoral bacteria (F. nucleatum, S. oralis, P. gingivalis) in both salineand saliva solutions. This testing varied the current levels, inoculumsize of bacteria, solution medium, and treatment time to develop anoptimal treatment to reduce these three bacteria species associated withboth periodontal and systemic diseases.

The results of this testing yielded unexpected results and showed thateach different bacterium had a different dose response to DCstimulation. Through this testing, the applicants identified treatmentparameters that were able to kill up to 100% of S. oralis, 99.1% of F.nucleatum, and 52.3% of P. gingivalis in a single treatment lastingthirty minutes or less. This research yielded specifications forDC-based treatments of targeted pathogens that was previously unknown inthe art. The optimal treatment parameters discovered in this researchand described in this method can provide an innovative way to reducethese three species of bacteria, in both supra- and sub-gingivalenvironments, and thus prevent and/or treat their associatedcomplications including periodontal disease, biofilm formation, as wellas the systemic diseases correlated to these oral pathogens.

In addition, scanning electron microscopy (SEM) was conducted on F.nucleatum colonies before and after at 30 minute treatment, according tothe method of this invention, to better understand the mechanism bywhich the method according to this invention is able to reduce bacteriallevels. The SEM imagery suggested that the method according to thisinvention interferes with bacterial cellular division and can weaken theouter envelope (cell membrane) resulting in fragile cellular structuresthat can easily break. It is contemplated that this is phenomenon is anexample of electroporation, where the permeability of cellular membranesmay be affected by electrical stimulation either temporarily orpermanently. It is further contemplated that the electroporation causedby the method according to this invention could play a role indeveloping new therapies in molecular biology which would take advantageof this cellular permeability and introduce new material into the cellsof oral pathogens or oral tissues through mechanisms including, but notlimited to genetic material (transfection) such as DNA, RNA, sRNA,siRNA, plasmids, etc. These effects would prove a new tool in targetedgene therapies for oral applications.

Specifically, the method according to the present invention has beenshown to reduce viable colony forming units (CFU) in various oralbacteria.

Table 1 below shows the efficacy of treatment according to the presentinvention at current levels of 50 μA or 500 μA for 5, 10, 20 and 30minute durations for bacterial cultures ranging from 10⁴ to 10⁷ colonyforming units (CFU) of Streptococcus oralis in a saline solution.

TABLE 1 In Vitro Efficacy of Device Against Streptococcus oralis inSaline CFU μA 0 Min 5 Min 10 Min 20 Min 30 Min 10e4  50 μA 1120 1080 600320 280 500 μA 1120 1200 800 240 0 10e5  50 μA 10000 9600 8400 9200 7600500 μA 11600 10400 11200 10800 8400 10e6  50 μA 80000 63200 52800 3240024800 500 μA 80800 70000 15200 14000 15600 10e7  50 μA 1280000 10800001040000 800000 440000 500 μA 1080000 520000 160000 120000 320000

Table 2 below shows the efficacy of treatment to the present inventionat current levels of 50 μA or 500 μA for 5, 10, 20 and 30 minutedurations for bacterial cultures ranging from 10⁴ to 10⁷ CFU ofStreptococcus oralis in a saliva solution.

TABLE 2 In Vitro Efficacy of Device Against Streptococcus oralis inSaliva CFU μA 0 Min 5 Min 10 Min 20 Min 30 Min 10e4  50 μA 160 160 80 8040 500 μA 200 80 80 80 80 10e5  50 μA 5600 5600 6800 5600 4000 500 μA8400 6800 7200 6400 2800 10e6  50 μA 25600 25200 15200 17200 18400 500μA 23600 16800 15600 17600 15200 10e7  50 μA 316000 284000 300000 276000220000 500 μA 324000 328000 300000 292000 252000

Table 3 below shows the efficacy of treatment to the present inventionat current levels of 50 μA or 500 μA for 5, 10, 20 and 30 minutedurations for bacterial cultures ranging for 10⁴ and 10⁶ CFU ofFusobacterium nucleatum in a saline solution.

TABLE 3 In Vitro Efficacy of Device Against Fusobacterium nucleatum inSaline CFU μA 0 Min 5 Min 10 Min 20 Min 30 Min 10e4  50 μA 480 280 280120 40 500 μA 560 440 400 200 120 10e6  50 μA 94000 91600 85600 7040084400 500 μA 46400 45600 27200 2000 400

Table 4 below shows the efficacy of treatment according to the presentinvention at current levels of 50 μA or 500 μA for 5, 10, 20 and 30minute durations for bacterial cultures ranging from 10⁴ to 10⁶ CFU ofFusobacterium nucleatum in saliva.

TABLE 4 In Vitro Efficacy of Device Against Fusobacterium nucleatum inSaliva CFU μA 0 Min 5 Min 10 Min 20 Min 30 Min 10e4  50 μA 1480 14801560 680 880 500 μA 2360 2360 1720 1240 1080 10e5  50 μA 19600 1960015200 14400 14000 500 μA 18000 17200 14400 11200 10800 10e6  50 μA348000 112000 120000 72000 68000 500 μA 156000 128000 124000 32000 28000

Table 5 below shows the efficacy of treatment to the present inventionat current levels of 50 μA or 500 μA for 5, 10, 20 and 30 minutedurations for bacterial cultures ranging for 10⁵ CFU of Porphyromonasgingivalis in a saline solution.

TABLE 5 In Vitro Efficacy of Device Against Porphyromonas gingivalis inSaline CFU μA 0 Min 5 Min 10 Min 20 Min 30 Min 10e4  50 μA 3440 20402720 1640 1640 500 μA 2440 2120 2200 1880 1840

Thus, this method and corresponding apparatus are able to achievemultiple prophylactic, therapeutic, and regenerative effects whosecombination was not previously known or available in the art. Namely,these effects are: promotion of oral osteogenesis, destruction ordisabling of oral microbes, gingival tissue regeneration, reduction andprevention of the formation of oral biofilms, caries prevention,increased oral vasodilation and oral blood flow, treatment of commonoral conditions such as gingivitis and periodontitis, treatment ofsystemic diseases and conditions correlated with oral pathogens, andgenerally improved oral hygiene.

These effects are accomplished by the delivery of direct current to thegingiva through a plurality of electrodes in direct contact with thelingual and buccal gingival surfaces. The electrodes may be fashionedout of any electrically-conductive material, including but not limitedto metals such as silver, stainless steel, copper, gold, platinum,palladium, aluminum, an alloy thereof, electrically-conductivenanotubes, carbonized rubber, electrically-conductive silicone, orelectrically-conductive polymers. The electrodes may be composed of thesame or of differing materials. These electrodes fit snuggly against thelingual and buccal sides of the gingiva and make direct contact witheach side of the gingiva to pass direct current electricity across theteeth and neighboring gingival tissues.

The electrodes on each side (lingual or buccal) of the gingiva are ofthe same polarity. Electrodes on opposite sides of the gingiva are ofthe opposite polarity. This allows the current to flow across the teethand gums to the electrodes positioned on the transverse gingiva tocomplete the electrical circuit. Put another way, all electrodes on thelingual side of the gingiva will be completely anodic or completelycathodic. All electrodes on the buccal surfaces of the gingiva,transverse the lingual surfaces of the gingiva, would have the oppositepolarity. The polarization of these electrodes may be reversed duringtreatment or in between treatments.

The mandibular and maxillary gingiva each have a set of a plurality ofpolarized electrodes as previously described. This allows for treatmentof both the maxillary and mandibular periodontium either simultaneouslyor in isolation. The maxillary and mandibular sets of electrodes may bepowered by two different adjustable power supplies or by the sameadjustable power supply.

Electrical conductors then connect these electrodes to an adjustablepower supply. All of the anodic electrodes will connect to the positivepole of the power supply and all of the cathodic electrodes will connectto the negative pole of the power supply. The adjustable power supply iscapable of delivering a stable, direct current in the approximate rangeof 1 to 500 microamperes. The preferred current setting for mosttreatments is in the approximate range of 50 to 250 microamperes.

In order to increase conductivity in the tissues adjacent to theelectrodes, an ionic or colloidal liquid or gel may be used as aconductive medium to decrease electrical resistance in the mouth. Thismedium would be placed along any desired areas of desired electricalcontact, such as the teeth, gums, or surrounding oral tissues. Examplesof such a medium would include, but not be limited to, colloidal silvergel, liquid colloidal silver, colloidal copper gel, liquid colloidalcopper, colloidal gold gel, liquid colloidal gold, saline gel, liquidsaline or any combination thereof.

Colloidal silver, in whole or in combination, has great promise not onlyin increasing electrical current flow, but also in offering additionalbactericidal benefits. Colloidal silver, in concentrations as little asfive parts per million, is known to be bactericidal by inhibiting abacterium's production of adenosine triphosphate.

This conductive medium may also contain dietary supplements including,but not limited to, oil of oregano. Oil of oregano is believed to havemany health benefits and may also be microbicidal. Such microbicidalproperties would be effective in treating common oral infections anddiseases as well as aiding in preventative oral care.

This conductive medium may also contain teeth whitening agents. Thiswould allow for the addition of teeth whitening to the list of benefitsoffered by an embodiment of this invention. A whitening agent that iscatalyzed by direct current electricity could be included and may evenoffer reduced teeth whitening treatment times when compared withnonelectrically-catalyzed whitening agents.

Artificial or natural flavorings may also be added to this conductivemedium to offer a more appealing taste to the user, similar to themethod of flavoring dental fluoride treatments. This flavoring wouldmask any unpleasant tastes from the ingredients of the conductive mediumor as well as any taste of the mouthpiece or electrodes themselves.

FIG. 1 shows one embodiment of a treatment apparatus according to thisinvention. A user input device 120 is connected to a microcontrolleddirect current power supply 110. This input device 120 may include, butnot be limited to potentiometer dials, push buttons, switches, toggles,etc. User input device 120 allows the patient to control various aspectsof the treatment including but not limited to power on or off, outputcurrent levels, treatment program selection, treatment duration,treatment reminders, polarity, etc. Input device 120 may also be used torun pre-programmed treatment regimens as described by this methodtargeted at specific pathogens, including but not limited to, S. oralis,P. gingivalis, and F. nucleatum. Microcontrolled power supply 110 readsthe state of input device 120 and adjusts the output current tocompensate for the continually varying resistance across cathodicelectrodes 140 and anodic electrodes 150.

An optional user feedback device 130 is shown in FIG. 1 connected tomicrocontrolled power supply 110. Feedback device 130 may containvarious methods and devices capable of relaying treatment information tothe user. Feedback device 130 could include, but not be limited to anLCD display, LCD matrix display, color LCD displays, indicator LEDs, LEDbar graphs, LED segment displays, OLED displays, audio speakers,vibrating devices, or any combination thereof. Feedback device 130offers the user information including, but is not limited to, outputcurrent level, treatment time elapsed, treatment time remaining, date,time of day, battery power level, treatment reminder indicators or soundalarms, recharging indicators, etc. Feedback device 130 also providesinformation regarding any state change from input device 120. Thisallows the user to receive information on how his/her input is affectingthe treatment. Feedback device 130 is not required for the operation ofthis embodiment of the treatment apparatus and may be omitted.

Microcontrolled power supply 110 contains a microcontroller 112 and adirect current power source 116. Microcontroller 112 is electricallyconnected to input device 120 and is capable of reading the device'sstate(s). Microcontroller 112, upon reading these state(s), is able todynamically adjust the output of power source 116. This allows the userto control the level of current generated by the power source 116.Microcontroller 112 is also connected to an optional user feedbackdevice 130. Microcontroller 112 is able to output information related tothe treatment duration, current timer status, current levels, and otherinformation to feedback device 130. Microcontroller 112 also has timingcapabilities, represented by timer 114, that allow for limitingtreatment time based on some predetermined treatment duration. Timer 114is also used to output the elapsed treatment time to feedback device130, if present. The user is able to input desired treatment parameterssuch as treatment duration, treatment current levels, etc. tomicrocontroller 112 by way of input device 120.

The programmable nature of microcontroller 112 allows for advancedfunctionality not present in other oral electrical treatment devices.For example, the software on microcontroller 112 could be programmed torun a predetermined treatment regimen. This treatment regimen couldinclude but not be limited to such factors as: treatment duration,targeted pathogen, treatment current levels, treatment time-of-day,treatment reminders, etc. This treatment regimen could also beprogrammed by a dental professional by way of input device 120 so that apatient's treatment may be simplified and guaranteed to follow setparameters.

Cathodic electrodes 140 are connected to the positive pole of powersource 116 and anodic electrodes 150 are connected to the negative poleof power source 116. These electrodes are placed in direct contact withthe gingiva, mounted transversely from one another. This allows acurrent flow from cathodic electrodes 140 to the gingival tissues,surrounding teeth, boney structures, and connected mouth tissues toanodic electrodes 150 mounted on the transverse gingiva and then back topower supply 110, forming a complete circuit.

Power source 116 may be any known device capable of delivering anadjustable direct electrical current. This includes, but is not limitedto disposable batteries, rechargeable batteries, AC-DC power converter,etc. Microcontroller 112 is able to regulate the current output of powersource 116 by a known method of electrical current control. Power supply116 is capable of delivering a direct current of between 1 and 500microamperes, with an approximate range of 50 to 250 microamperes usedfor most treatments. Microcontroller 112 is also able to reverse thepolarity of the cathodic electrodes 140 and anodic electrodes 150 bycontrolling the output of power source 116. This allows for dynamicchanging of electrode polarity during treatment. Microcontroller 112 isalso programmable to allow for pulsed application of direct currentacross the gingiva.

FIG. 2 shows a top-down view of another embodiment of the treatmentapparatus. In this embodiment, a mouthpiece unit 200, known in the art,has two electrodes attached to or embedded in it, and is worn in themouth. A single lingual gingiva electrode 210 fits snugly against thelingual gingival tissue of the mouth. A single buccal gingiva electrode220 is attached to or embedded in mouthpiece 200 so that it istransverse from the lingual gingiva electrode 210 and fits snuglyagainst the buccal gingival tissues of the mouth. Two electricalconductors 230 connect electrodes 210 and 220 to an adjustable currentpower supply, of whose embodiment may be similar to that of 110 or thatof FIG. 3. Electrical conductors 230 are insulated so that a shortcircuit does not occur inside or outside of the mouth. Electricalconductors 230 are shown as attached to the anterior of mouthpiece 200,but may be electrically connected to electrodes 210 and 220 at any pointalong mouthpiece 200, so long as electrical conductors 230 are notattached to the same electrode. Electrical conductors 230 may also bepartially or wholly composed of an electrically conductive polymer.

FIG. 3 shows a perspective view of the same type of embodiment shown inFIG. 2. A mouthpiece 300 has a lingual gingiva electrode 310 and abuccal gingiva electrode 320 attached to or embedded it. Electrodes 310and 320 span the lingual and buccal gingival surfaces of the mouth,respectively. A set of embedded electrical conductors 340 are connectedto electrodes 310 and 320 on one end and on the other end to a set ofconductors to the power supply 330. Conductors 340 are embedded in themouthpiece material and are electrically insulated. Conductors 330 thenconnect to the positive and negative poles of a direct current powersource, similar to that of 110 or FIG. 6.

FIG. 4 presents another embodiment similar in nature to that of FIGS. 2and 3. In this embodiment, electrode sets are attached to or embedded ina mouthpiece unit 400. A set of lingual gingiva electrodes 410 areaffixed to or embedded in mouthpiece 400. Electrode set 410 comprises aplurality of discrete lingual gingiva electrodes 4102, which areelectrically connected by embedded electrical conductors 4104.Conductors 4104 are insulated and are embedded in or attached tomouthpiece 400. Likewise, a set of buccal gingiva electrodes 420 areaffixed to or embedded in mouthpiece 400 transverse of electrode set410. Electrode set 420 comprises a plurality of discrete lingual gingivaelectrodes 4202, which are electrically connected by embedded electricalconductors 4204. Conductors 4204 are insulated and are embedded in orattached to mouthpiece 400. This embodiment allows for multiple,discrete points of electrical contact within the mouth. In FIG. 4,conductors to the power supply 430 are shown as attached to theposterior electrodes in mouthpiece 400. However, conductors 430 may beelectrically connected to any point of electrode sets 410 and 420, solong as conductors 430 are not connected to the same electrode set.Conductors 430 then connect to the positive and negative poles of adirect current power source, similar to that of 110 or FIG. 6.

FIG. 5 offers a perspective view of an embodiment similar to FIG. 4. Alingual gingiva electrode set 510 and a buccal gingiva electrode set 520are attached to or embedded in a mouthpiece 500. Electrode set 510comprises a plurality of lingual gingiva electrodes 5102 that areelectrically connected by embedded electrical conductors 5104.Conductors 5104 are electrically insulated and are embedded in orattached to mouthpiece 500. Similarly, electrode set 520 comprises aplurality of buccal gingiva electrodes 5202 that are electricallyconnected by embedded electrical conductors 5204. Conductors 5204 areelectrically insulated and are embedded in or attached to mouthpiece500. Electrode set 520 is mounted transverse of electrode set 510 toallow direct current to flow across the tissue of the teeth and gums.Electrode sets 510 and 520 are connected to conductors to the powersupply 530 by way of embedded electrical conductors 540. Conductors 540are electrically-insulated and are embedded in mouthpiece 500.Conductors 530 then connect to the positive and negative poles of adirect current power source, similar to that of 110 or FIG. 6.

FIG. 6 presents another embodiment of an adjustable direct current powersource used to supply direct current to a plurality of oral electrodes.This particular circuit design is capable of delivering a steady currentregardless of moderate fluctuations in the resistance between theelectrodes. The circuit uses a 9-volt power supply 640, which could be adisposable battery, a rechargeable battery, an AC-to-DC converter, orany other suitable 9-volt power source. A dual unit, three-port switch610 is used to select the current level in the circuit. The threeoptions of the switch circuit are power off 614, 100 μA 612, or 200 μA616. Switch option 614 simply does not complete a circuit, preventingcurrent from flowing. Switch option 612 comprises a 332 kΩ resistor 618in series with a 2 volt LED 620. These two components are in parallelwith a 48.7 kΩ resistor 622 to provide a 100 microamp current. TheSwitch option 616 comprises a 665 kΩ resistor 624 in series with a 2volt LED 626. These two components are in parallel with a 97.6 kΩresistor 628 to provide a 200 microamp current. Cathodic upper mouthelectrodes 630 and cathodic lower mouth electrodes 632 are in parallelwith each other and are electrically connected to the output of switch610. Electrical current then travels from power supply 640 to theseelectrodes, through the gingival tissues of the mouth to anodic uppermouth electrodes 636 and anodic lower mouth electrodes 634 and finallyback to power supply 640. This circuit design will allow moderate andreasonable fluctuations in the resistance across the electrodes andprevent over driving the circuit should the resistance in the mouthvary.

In another embodiment of this invention or in combination with thosepreviously described, an ionic or colloidal medium in the form of aliquid or a gel may be used to decrease electrical resistance in themouth and to facilitate a more even current distribution across oralelectrodes. Any combination of one or more ionic or colloidal compoundsmay be used. Examples of such a medium would include, but not be limitedto, colloidal silver gel, liquid colloidal silver, colloidal copper gel,liquid colloidal copper, colloidal gold gel, liquid colloidal gold,saline gel, liquid saline or any combination thereof. Artificial ornatural flavorings may be added to this medium to offer a more appealingtaste to the user. The medium may also contain dietary supplementsincluding, but not limited to, oil of oregano. This medium may alsocontain teeth-whitening chemical agents. A whitening agent that iscatalyzed by the direct current would be most effective in this ionic orcolloidal medium.

In yet another embodiment, microcontrolled power supply 110 would beminiaturized and be physically attached to or embedded in a mouthpiecesimilar to 200, 300, 400, or 500. This would allow for an all-in-oneunit that would fit inside the user's mouth. In this embodiment, powersource 116 would have to be of small physical size. One of many possibleoptions is a watch-type battery or other small, portable power source.This circuitry would then be encased in a waterproof manner in thematerial of the mouthpiece itself. Input device 120 and feedback device130 would be waterproofed and protected from any kind of electricalshorting, as well.

Thus the reader will see that at least one embodiment addresses adesired need in the oral hygiene and dental fields to concurrently treatcommon oral diseases and conditions in a more effective, less invasive,and less expensive manner. These embodiments promote general oralhygiene, reduce oral biofilm, treat periodontal diseases such asgingivitis and periodontitis, kill oral microbes including bacteria andthus preventing cavities and tooth decay, increase vasodilation andblood flow in oral tissues, promote gingival tissue regeneration, fosterosteogenesis in the boney structures of the teeth, mouth, and relatedareas, treat systemic diseases related to oral pathogens, and treatother periodontal and oral maladies through the non-invasive applicationof weak direct current electricity to the surfaces in the oral cavity.

While our above descriptions contain many specificities, these shouldnot be construed as limitations on the invention, but rather as anexemplification of several preferred embodiments thereof. Many othervariations are possible. For example, electrodes may be attacheddirectly to the gingiva without the use of a mouthpiece, perhaps usingan electrically-conductive paste. Or electrodes may be placed in contactwith tissues neighboring the gingiva, such as the teeth or tissues ofthe cheek, instead of directly on the gingiva to accomplish the sameresult. Another example would be replacing LEDs 626 and 620 from FIG. 6with standard diodes to achieve the same resultant circuit. Overall, thecircuitry from FIGS. 1 and 6 could be altered in many ways to deliverthe same electrical current to the oral electrodes.

In some cases dental procedures can break up oral bacterial coloniesfound in biofilms and introduce bacteria into the bloodstream causingbacteremia and other infections. It is further contemplated that it maybe desirable to utilize a mouthpiece according to the present inventionimmediately prior to performing a dental procedure. The mouthpieceaccording to this invention may be used by the patient either at home orin the dental office. In this manner, the living bacteria in thepatient's mouth, both supra- and sub-gingival, can be reduced prior tothe procedure and the risk of bacteremia and other infections will bereduced. For example, and not by way of limitation, a mouthpieceaccording to the present invention may be utilized prior to a dentalprophylaxis or a scaling and root planning procedure in a dental officeto reduce the risks of introducing bacteria into the patient's bloodstream. Such a pre-procedural treatment would be used for approximately10 to 20 minute with a current level ranging from 50 μA to 500 μA andwould be timed to conclude immediately before the procedure.

A mouthpiece according to the present invention may also be utilizedfollowing a clinical procedure as prevention for infections, forscenarios including but not limited to post-extraction orpost-implantation infection prevention. Such a post-procedural treatmentwould last for approximately 10 to 20 minutes with a current rangingfrom 50 μA to 500 μA. This procedure may then be repeated at home by thepatient one or more times a week until the risk of infection has passed.

Prevention of Systemic Disease

It is contemplated that a mouthpiece according to the present inventionmay be used to prevent or treat systemic diseases as will be outlined inmore detail below. The method according to the present invention hasbeen shown to be effective in reducing the amount of oral bacteria,specifically F. nucleatum, P. gingivalis, and S. oralis.

1. Cardiovascular Disease

It is contemplated that use of a mouthpiece according to the presentinvention may be used to reduce microbial burdens caused by thetranslocation of oral bacteria, including but not limited to S. oralis,P. gingivalis, and F. nucleatum, from the gingival tissues to the restof the body and also decrease the amount of inflammatory mediatorsproduced by oral bacteria. Further, by reducing F. nucleatum, it iscontemplated that the ability of P. gingivalis to invade host cells willbe lessened and thus diminishing the development of bacteremia that hasbeen linked with the initiation/worsening of atherosclerosis andcoronary heart disease.

It is contemplated that a mouthpiece according to the present inventionmay be used according to a predetermined treatment regimen to prevent,treat and/or mitigate cardiovascular disease. In the predeterminedtreatment regimen, the patient will wear a mouthpiece according to thepresent invention for a predetermined amount of time at a predeterminedcurrent level and at predetermined time intervals. It is furthercontemplated that the specific treatment regimen may be determined basedon the bacterial levels present in a patient. According to oneembodiment of the invention, the treatment regimen would consist of apatient wearing a mouthpiece according to the present invention for 20minutes once per day at a current level of 500 μA. For acutecardiovascular conditions, this treatment may continue on a daily basisuntil the conditions is resolved. For chronic cardiovascular disease,this treatment may be repeated a few times a week on a continuing basis.

2. Still Birth

It is further contemplated that a treatment with a mouthpiece accordingto the present invention according to a predetermined treatment protocolwould reduce the oral population of F. nucleatum associated withperiodontal disease and thus prevent, treat and/or mitigate still birth.In turn, this reduction would lessen the likelihood of F. nucleatumtranslocating from the oral cavity into the bloodstream, where it couldthen migrate into the placenta and colonize. It is contemplated that amouthpiece according to the present invention may be used according to apredetermined treatment regimen to prevent still birth. In thepredetermined treatment regimen, the patient will wear a mouthpieceaccording to the present invention for a predetermined amount of time ata predetermined current level and at predetermined time intervals. It isfurther contemplated that the specific treatment regimen may bedetermined based on the bacterial levels present in a patient. Accordingto one embodiment of the invention, the treatment regimen would consistof a patient wearing a mouthpiece according to the present invention for20 minutes once per day at a current level of 500 μA for the duration ofthe pregnancy. The treatment parameters outlined above have beendemonstrated to be highly efficient at reducing levels of S. oralis andF. nucleatum at inoculation sizes of 10⁷ colony-forming units (CFU).

3. Diabetes

It is contemplated that a mouthpiece according to the present inventionaccording to a predetermined treatment protocol may be used to prevent,treat and/or mitigate diabetes by causing a reduction of S. oralis inthe oral cavity and consequently reduce the amount of serum markers ofinflammation produced by bacterial infections. In the predeterminedtreatment regimen, the patient will wear a mouthpiece according to thepresent invention for a predetermined amount of time at a predeterminedcurrent level and at predetermined time intervals. It is furthercontemplated that the specific treatment regimen may be determined basedon the bacterial levels present in a patient. According to oneembodiment of the invention, the treatment regimen would consist of apatient wearing a mouthpiece according to the present invention for 20minutes once per day at a current level of 500 μA to effectively reduceoral levels of S. oralis that in turn will lower the amount of systemicinflammatory markers. This treatment may be repeated multiple times aweek on an ongoing basis to help reduce inflammatory markers.

4. Pyogenic Liver Abscess

It is contemplated that a mouthpiece according to the present inventionaccording to a predetermined treatment protocol may be used to prevent,treat and/or mitigate pyogenic liver abscess by causing a reduction ofF. nucleatum. Specifically, it is contemplated that treatment with amouthpiece according to the present invention would reduce bacteriallevels and may stop F. nucleatum and other oral bacteria species fromtraveling to the liver and reduce overall bacteremia. In thepredetermined treatment regimen, the patient will wear a mouthpieceaccording to the present invention for a predetermined amount of time ata predetermined current level and at predetermined time intervals. It isfurther contemplated that the specific treatment regimen may bedetermined based on the bacterial levels present in a patient. Accordingto one embodiment of the invention, the treatment regimen would consistof a patient wearing a mouthpiece according to the present invention for20 minutes once per day at a current level of 500 μA to effectivelyreduce oral levels of F. nucleatum which may prevent any bacteria frombeing transported from the oral cavity systemically. This treatment maybe repeated multiple times per week until the abscess is reduced.

5. Osteomyelitis

It is contemplated that a mouthpiece according to the present inventionaccording to a predetermined treatment protocol may be used to prevent,treat and/or mitigate osteomyelitis by causing a reduction of F.nucleatum. In the predetermined treatment regimen, the patient will weara mouthpiece according to the present invention for a predeterminedamount of time at a predetermined current level and at predeterminedtime intervals. It is further contemplated that the specific treatmentregimen may be determined based on the bacterial levels present in apatient. According to one embodiment of the invention, the treatmentregimen would consist of a patient wearing a mouthpiece according to thepresent invention for 20 minutes per treatment at a current level of 500μA to effectively reduce oral levels of F. nucleatum bacteria andprevent any bacteria from being transported from the oral cavitysystemically. This treatment may be used in conjunction with or separatefrom standard antibiotic-based treatments for osteomyelitis. When usedin conjunction with antibiotics, treatment will normally continue forapproximately 29 to 42 days. When used separately from antibiotics, thistreatment may be used once a day for a few months for acute conditions,or a few times a week on a continuing basis for chronic conditions.

6. Arthritis

It is contemplated that a mouthpiece according to the present inventionaccording to a predetermined treatment protocol may be used to prevent,treat and/or mitigate arthritis by causing a reduction of F. nucleatum.In the predetermined treatment regimen, the patient will wear amouthpiece according to the present invention for a predetermined amountof time at a predetermined current level and at predetermined timeintervals. It is further contemplated that the specific treatmentregimen may be determined based on the bacterial levels present in apatient. According to one embodiment of the invention, the treatmentregimen would consist of a patient wearing a mouthpiece according to thepresent invention for 20 minutes once per day at a current level of 500μA to effectively reduce oral levels of F. nucleatum bacteria andprevent any bacteria from being transported from the oral cavity andtranslocating to the synovial fluid and reducing the associatedinflammation. This treatment may be repeated multiple times per week ona continual basis for this type of chronic condition.

Reducing Bio Film and Preventing Bio Film Formation

It is contemplated that a mouthpiece according to the present inventionaccording to a predetermined treatment protocol may be used to prevent,treat and/or mitigate oral biofilm by causing a reduction of F.nucleatum, P. gingivalis, and/or S. oralis, all of which are involved inoral biofilm formation. In the predetermined treatment regimen, thepatient will wear a mouthpiece according to the present invention for apredetermined amount of time at a predetermined current level and atpredetermined time intervals. It is further contemplated that thespecific treatment regimen may be determined based on the bacteriallevels of specific bacterial species present in a patient. According toone embodiment of the invention, the treatment regimen would consist ofa patient wearing a mouthpiece according to the present invention for 20minutes once per day at a current level of 500 μA to effectively reduceoral levels of F. nucleatum bacteria to prevent further biofilmformation caused by F. nucleatum and to reduce the viability of existingbiofilm colonies of F. nucleatum.

According to another embodiment of this invention, the treatment regimenwould consist of a patient wearing a mouthpiece according to the presentinvention for 20 minutes once per day at a current level of 50 μA toeffectively reduce oral levels of P. gingivalis bacteria to preventfurther biofilm formation caused by P. gingivalis and to reduce theviability of existing biofilm colonies of P. gingivalis.

Furthermore, according to another embodiment of this invention, thetreatment regimen would consist of a patient wearing a mouthpieceaccording to the present invention for 20 minutes once per day at acurrent level of 500 μA to effectively reduce oral levels of S. oralisbacteria to prevent further biofilm formation caused by S. oralis and toreduce the viability of existing biofilm colonies of S. oralis.

These treatments for biofilm reduction and prevention may be repeated ona daily basis for a three to six weeks for acute biofilm-based issues ormay be repeated once or more per week on a continuing basis for chronicbiofilm issues.

Treatment of Non-Human Animals

Systems and methods according to the present invention may be used toreduce oral bacteria and/or biofilm, as well as to treat systemicdiseases that may be associated with oral bacteria, in non-humananimals, such as dogs, cats, sheep, horses, cows, pigs, etc.

For instance, periodontal disease is one of the most common healthproblems affecting dogs (>75%). The prevalence of periodontal diseasehas been found to increase age but decrease with body weight. Varioussystemic diseases have been suggested as a strong co-factor forperiodontal disease in animals, just as in humans. It has been suggestedthat periodontal disease could have a causal relationship with systemicdiseases in both humans and animals. For dogs, and animals in general,periodontitis is a recurrent and persistent disease and exposes the hostto negative systemic effects over an extended period of time, e.g.several years.

It has been observed that, over the course of several years, frequentexposure of bacteremia as a result of minor trauma at sites ofperiodontal inflammation may cause infection or induce inflammation atdistant sites with the body. The pathogenesis of periodontal disease indogs has been linked with gram-negative anaerobic bacteria uponaccumulation within the gingival sulcus causing inflammation and theformation of periodontal pockets. The inflammatory response toperiodontal pathogens promotes the formation and release of endotoxinsand inflammatory cytokines that can decrease functions of vital organsover time. It has been suggested that systemic diseases may beassociated with periodontal disease in dogs, including chronicbronchitis, pulmonary fibrosis, endocarditis, interstitial nephritis,glomerulonephritis, and hepatitis.

Periodontal organisms present in dogs with periodontitis have beenisolated and identified previously. For instance, the followingperiodontal pathogens have been found to be associated with periodontaldisease in dogs: P. gingivalis (64% of periodontitis-positive dogs), C.rectus, A. actinomycetemcomitans, P. intermedia, T. forsythensis, F.nucleatum (4% of periodontitis-positive dogs), E. corrodens, P.denticanis, P. gulae, P. salivosa. Recommended treatments using systemsand/or methods according to the present invention to treat and/orprevent periodontal disease by reducing or controlling such types ofbacteria, may include a predetermined time, such as 20 minutes, of oralsecretions and/or tissue (i.e., saliva, lingual tissue, dental tissue,gingival tissue, periodontal tissue, and/or oral mucosa tissue) exposureto an electrical current (alternating or direct current, constant orpulsed) level of between about 50 microamps (μA) and about 500 microamps(μA). Devices according to the present invention have been shown to beeffective at reducing the count of bacterial species in this currentrange.

As with dogs, periodontal disease in cats is associated with localinflammation and is purported to influence and induce systemic responsesand organ function in distal sites. One of the common oral pathogensfound in the oral cavity of cats is P. gingivalis. Studies havedemonstrated that indeed measureable systemic changes arise during theprogression of periodontal disease, such as increased levels of serumIgG. Further, these levels could be altered with periodontal treatment.Recommended treatments using systems and/or methods according to thepresent invention to treat and/or prevent periodontal disease in cats byreducing or controlling such types of bacteria, may include apredetermined time, such as 20 minutes, of oral tissue exposure to anelectrical current (alternating or direct current, constant or pulsed)level of between about 50 microamps (μA) and about 500 microamps (μA).Devices according to the present invention have been shown to beeffective at reducing the count of such bacterial species in thiscurrent range.

Periodontitis may also be found in sheep, also referred to as “brokenmouth”, and is associated with severe degradation of periodontalcollagen, loss of alveolar bone, appearance of periodontal pockets andpremature tooth loss. Although morphological and histologicaldifferences exist between the periodontium of sheep and humans, thehistopathological appearance is similar in periodontal disease,including the role that P. gingivalis plays in the progression of thedisease. Recommended treatments using systems and/or methods accordingto the present invention to treat and/or prevent periodontal disease insheep by reducing or controlling such types of bacteria, may include apredetermined time, such as 20 minutes, of oral tissue exposure to anelectrical current (alternating or direct current, constant or pulsed)level of between about 50 microamps (μA) and about 500 microamps (μA).Devices according to the present invention have been shown to beeffective at reducing the count of such bacterial species in thiscurrent range.

Cardiovascular-related conditions may also exist in non-human animals.For instance, there has in dogs been revealed an association betweenperiodontal disease severity and risk of cardiovascular-relatedconditions, such as endocarditis and cardiomyopathy. Endocarditis is aresult of infection and inflammation of the heart endothelium, or tissuelining the inner surface of the heart valves and can be caused byvarious microorganisms. Cardiomyopathy is characterized by an enlargedheart that does not function properly. Both diseases carry a poorprognosis based on the severity of the case. For dogs, it has been foundthat the risk of endocarditis was 6-fold higher in dogs with stage 3periodontal disease than it was for healthy dogs and for cardiomyopathyit was about 4-fold. Cardiac disease progression may be affected by thepresence and/or prevalence of certain oral bacteria, including S.oralis, F. nucleatum, and P. gingivalis. Recommended treatments usingsystems and/or methods according to the present invention to treatand/or prevent cardiac disease by reducing or controlling such types ofbacteria, may include a predetermined time, such as 20 minutes, of oraltissue exposure to an electrical current (alternating or direct current,constant or pulsed) level of between about 50 microamps (μA) and about500 microamps (μA). Devices according to the present invention have beenshown to be effective at reducing bacterial burden of all three speciesin this current range.

In addition to cardiac disease, a prior retrospective longitudinal studyhas established a relationship between periodontal disease and chronickidney disease (CKD). The hazard ratio of CKD in dogs, in conjunctionwith increased serum creatinine and blood urea nitrogen concentrations,has been shown to increase, with increasing severity of periodontaldisease, from stage 1 to stage 4, thereby establishing a significantpositive association between periodontal disease and CKD.

Both F. nucleatum and P. gingivalis are common oral pathogens presentedin dogs, and may be linked to kidney disease. Accordingly, reduction ofsuch pathogens may be used as a treatment or prevention thereof.Recommended treatments using systems and/or methods according to thepresent invention to treat and/or prevent kidney disease by reducing orcontrolling such types of bacteria, may include a predetermined time,such as 20 minutes, of oral tissue exposure to an electrical current(alternating or direct current, constant or pulsed) level of betweenabout 50 microamps (μA) and about 500 microamps (μA). Devices accordingto the present invention have been shown to be effective at reducing thecount of such bacterial species in this current range.

Non-human animal diabetes may also be treated and/or prevented usingsystems and methods according to the present invention. In humans, asstated, there is an established link between diabetes mellitus andperiodontal disease, and such a relationship has been suspected inveterinary medicine. One prior study has demonstrated that blood glucoseconcentrations are increased in relation to attachment loss andperiodontal disease state in dogs. Additionally, these levels decreasedfollowing periodontal disease treatment.

The S. oralis bacterium has been associated with severe periodontitisand diabetes. Recommended treatments using systems and/or methodsaccording to the present invention to treat and/or diabetes by reducingor controlling such types of bacteria, may include a predetermined time,such as 20 minutes, of oral tissue exposure to an electrical current(alternating or direct current, constant or pulsed) level of betweenabout 50 microamps (μA) and about 500 microamps (μA). Devices accordingto the present invention have been shown to be effective at reducing thecount of such bacterial species in this current range. Such a reductionmay help combat high levels of blood glucose.

Furthermore, systems and methods according to the present invention maybe used to affect (preferably reduce and/or eliminate) the number oforal bacteria transferred between animals of different species, such asbetween a pet and its owner. It is well established that oral bacteria,including periodontal pathogens, can be transmitted between mothers andtheir children simply through everyday close contact. Therefore, it isnot unfounded that transmission of such bacteria may occur betweenhumans and their companion animals. One study investigated In fact, theprevalence of periodontal pathogen species in dogs and their owners toexamine the possibility of pet-to-owner transmission has been studied.P. gulae was detected in 71.2% of dogs in the study and 16% in theowners. Interestingly, P. gulae is extremely uncommon in the human oralcavity, and each owner who harbored the bacteria had a dog that testedpositive for the pathogen. Two additional species, E. corrodens and T.denticola, were found to correlate between owners and dogs indicatingthat oral bacteria species may be transmitted between dogs and theirowners.

The P. gulae bacterium, a member of the Porphyromonas genus found in theoral cavity of dogs, has been shown to share 60% homology with P.gingivalis. This suggests that P. gulae would respond similarly totreatment with the device as does P. gingivalis. Recommended treatmentsusing systems and/or methods according to the present invention toremedy and/or prevent the transfer of oral bacteria between animals ofdifferent species by reducing or controlling such types of bacteria, mayinclude a predetermined time, such as 20 minutes, of oral tissueexposure to an electrical current (alternating or direct current,constant or pulsed) level of between about 50 microamps (μA) and about500 microamps (μA). Either or both animals (e.g. a dog and/or its owner)may be so treated. Devices according to the present invention have beenshown to be effective at reducing the count of such bacterial species inthis current range. Such treatment should reduce levels of P. gulae anddiminish the possibility of pathogen transmission to the animal's owner.

The treatment times may be a constant treatment time (e.g. 20consecutive minutes) or treatments may be prescribed and/or deliveredfor a predetermined period of time (e.g. 1-60 minutes) within atreatment window (e.g. 24 hours, one week, one month, etc.) in shorterincremental treatments, such as two minutes, five times a day (toachieve 10 minutes of stimulation within a treatment window of 24hours).

Method of Manufacture

A mouthpiece according to the present invention may be formed using anymethod and means known in the art. In one embodiment of such a method, afirst mold 700 is provided. The first mold 700 preferably includes a topportion 710 and a bottom portion 720. Each portion of the first mold 700includes a sealing means for sealing the first mold 700. In theillustrated embodiment the sealing means take the form of a cap730A,730B. Each cap 730A,730B preferably has a first channel 740 and asecond channel 750 therethrough. The first mold 700 preferably includesone or more fill ports 760 and one or more vents 770.

The pieces of the first mold 700 are preferably cleaned. A plurality ofwires 780A,780B,780C,780D are then prepared and treaded through thefirst mold 700. In the preferred embodiment, the four wires780A,780B,780C,780D are threaded through the first mold 700 as shown inFIG. 8. Preferably a first and a second wire 780A,780B are threadedthrough the top cap 730A and through the first mold 700 and a third anda fourth wire 780C,780D are threaded through the bottom cap 730 B andthrough the first mold 700. Preferably the first wire 780A extendsthrough the first channel 740 in the top cap 730A and the second wire780 B extends through the second channel 750 in the top cap 730A.Similarly, preferably, the third wire 780C extends through the firstchannel 740 in the bottom cap 730B and the fourth wire 780D extendsthrough the second channel 750 in the bottom cap 730B. The first mold700 is then closed. A non-conductive material is then injected throughone or more fill ports 760 in the first mold 700. The first mold 700cavity is filled when material is coming out of all vents 770 in thefirst mold 700. The non-conductive material may be a thermoplastic, athermoplastic elastomer, a thermoset polymer, a room temperaturevulcanizing elastomer, or other polymer.

When the non-conductive material is cured, the first mold 700 ispreferably opened and the partially formed mouthpiece 790 is removedfrom the first mold 700. The plurality of wires 780A,780B, 780C,780D arenow encapsulated by the non-conductive material. Preferably a wire780A,780B,780C,780D is located in each of the four exposed channels 800of the mouthpiece 790. Preferably the first wire 780A is located in theinner upper channel 800A, the second wire 780B is located in the outerupper channel 800B, the third wire 780C is located in the inner lowerchannel 800C (not shown), and the fourth wire 780D is located in theouter lower channel 800D (not shown). The excess wire is then preferablytrimmed from the mouthpiece 790 and the remaining wire780A,780B,780C,780D is preferably inserted fully into its associatedchannel 800A,800B,800C,800D.

A second mold 810 is preferably provided. The second mold preferablyincludes a top portion 810A and a bottom portion 810B. In theillustrated embodiment, each of the top and bottom portions of thesecond mold 810 preferably includes a mold base 820A,820B, a centerpiece 830A,830B, a first insert 840A,840B, and a second insert850A,850B. The pieces of the second mold 850 are preferably designed toallow the channels 800A,800B,800C,800D of the mouthpiece 790 to befilled with an electrically-conductive material. The second mold 810preferably includes one or more fill ports 760 for filling the moldcavities. As there are four channels 800A,800B,800C,800D to be filled,the preferred embodiment includes four fill ports 760. Further, thesecond mold 810 preferably includes one or more vents 770. In theillustrated embodiment each cavity includes its own vent 770.

Preferably the pieces of the second mold 810 are cleaned and prepared.The second mold 810 is then assembled with the mouth piece 790 as shownin FIGS. 10-12B. Preferably, the bottom portion 810B of the second mold810 is assembled first, with the mouthpiece 790. The top portion 810A ofthe second mold 810 is then assembled. A conductive material is theninserted into each of the fill ports 760. The cavities are filled whenmaterial is coming out of all vents 770 in the second mold 810. Theconductive material is preferably a thermosetting elastomer, but mayalso be a thermoplastic, a thermoplastic elastomer, or other polymer.

After the conductive material is cured, the second mold 810 is openedand the finished mouthpiece 760 is removed. Preferably, the top half810A of the second mold 810 is removed first. The first 840A and secondinserts 850A are preferably removed first. The center piece 830A canthen be removed. The bottom half 810B of the second mold may then beremoved, again first removing the first 840B and second inserts 850B andthen the center piece 830B.

Another embodiment 900 of a treatment apparatus is shown in FIGS.14-17B. The treatment apparatus 900 comprises a first end 902, a secondend 904 opposite the first end 902, and a body 910 extending between andincluding the first end 902 and the second end 904.

While the ends 902,904 may be formed integrally with the body 910, atleast one of the first end 902 and the second end 904 may be separablefrom the body 910. The combination of the first end 902, the second end904, and the body 910 defines a cavity 920. A control board 930 withpower supply 932 is preferably configured to be positioned within thecavity 920 as shown in FIG. 17A.

As further shown in FIGS. 17A and 17B, at least one and preferably aplurality of cathodic electrodes 940 and at least one and preferably aplurality of anodic electrodes 942 are spaced about the body 910. Theelectrodes 940,942 may be spaced in an alternating fashion or in pairs.As shown here, the electrodes 940,942 extend substantiallylongitudinally along the body 910 and alternate cathodic electrode940/anodic electrode 942 about the body periphery. In the embodiment900, the body 910 has an oval-type cross-section providing a first longside 912 and an opposing second long side 914, and a first short side916 adjacent to the first long side 912 and the second long side 914,and a second short side 918 opposing the first short side 916. At leasttwo electrodes, one cathode and one anode, are provided and electricallyaccessible through the material forming the outer surface of the device.On the first long side 912, a cathodic electrode 940 and an anodicelectrode 942 may be placed adjacent to, but spaced from, one another.An alternating pattern of cathodic electrodes and anodic electrodes mayprovide a cathodic electrode 940 or an anodic electrode 942 on the firstshort side 916 depending on the placement of the electrodes 940 and 942on the first long side 912. This pattern may be continued on the secondlong side 914 and the second short side 918. One alternatingrelationship is further shown in schematic form in FIG. 18. It should benoted that alternative shapes and configurations that maintain a spacedcathodic electrode 940 and anodic electrode 942 configuration are withinthe scope of the present invention.

As discussed previously, the circuit will be completed by the animal'smouth. This is schematically represented in FIG. 18 by impedences R_(o),provided by the animal's mouth (e.g. saliva and/or oral tissues),extending between two or more electrodes. An alternating pattern of aplurality of cathodic electrodes 940 and a plurality of anodicelectrodes 942 may provide a higher likelihood of circuit completion, asthere is provided more opportunities therefore. As one of each type ofelectrode 940 and 942 come into contact with an animal's mouth or oraltissues or secretions, an electrical current flows from the contactedcathodic electrodes 940 to the saliva, gingival tissues, surroundingteeth, boney structures, and/or connected mouth tissues (R_(o)) to thecontacted anodic electrodes 942 and then back to a power supply 932,forming a complete circuit. The power supply 932 may be a simpledry-cell battery, a rechargeable battery, a capacitor, a kinetic energygenerator, a piezoelectric generator, a microcontrolled DC power supply(as previously discussed 110) or other power supply (such as amicrocontrolled AC power supply). Regardless of the power supply 932used, it is most preferable to control the amount of electrical currentdelivered by the treatment device to provide a relatively constantcurrent power source to provide up to about 500 microamps of direct oralternating current. Such control may be provided by a microcontrolleror discrete monitoring circuitry (such as through current and/orimpedance sensing), or optimal dry-cell design if expected impedancesare generally known. It is further contemplated by the present inventionthat the treatment apparatus 900 is preferably used by non-humananimals, such as felines, bovines, ovines, canines, equines, porcines,etc.

Furthermore, a conductive material 950 c,a is layered over the top ofthe electrodes 940,942, respectively. Preferably, the conductivematerial 950 comprises a resilient material (preferably durometer ShoreA range of about 25 to about 80, or even up to about 90-95) to encouragechewing of the treatment apparatus 900. As non-limiting examples, aconductive silicone, urethane, fluorosilicone, or other conductivepolymer or a conductive fabric (e.g. silver-plated nylon, or non-wovenconductive or conductive-through-adhesive fabric tape) may be used as,or as a part of, the covering material. Regardless of the coveringmaterial used, it is preferred that at least a portion of the materialforming the outer surface of the apparatus conducts electricity from thepower supply, or regulated amount thereof, to the animal's mouth. Theconductive material portions 950 are preferably separated bynon-conductive material 960, such as an insulative polymer (e.g.non-conductive silicone) or fabric, preferably having approximately thesame durometer Shore A hardness as the conductive material, or a similartooth feel thereto. Alternatively, in another preferred embodiment, thehardness of the non-conductive material 960 is less than that of theconductive material 950, such as about half.

The control board 930 and power supply 932 may be of any types known toprovide an ability to transfer the power of the power supply 932 to theelectrodes 940 and 942. Fully contemplated within the purview of thepresent invention are timers, audible and/or visible usage, activityand/or power indicators (e.g. beeper, buzzer, light-emitting diodes),motion activation, moisture activation, pressure activation, electricalcurrent intensity adjustment (e.g., based on sensed impedance between acathode 940 and an anode 942), and/or an on/off switch 934 to controlthe possible current delivery by the power supply 932. Optionally, amicrocontroller could be used, as previously described, to control thevarious functions and could record various treatment parameters and/ortreatment history in non-volatile memory to be analyzed in real-time orpost-treatment.

Further contemplated is the use of a method according to the presentinvention for promoting oral hygiene in non-human animals, such asfelines, bovines, ovines, canines, porcines, and/or equines. The methodcomprises the steps of providing a treatment apparatus comprising apower source and a plurality of electrodes electrically coupled to thepower source. The power source may be an internal direct current powersource, or other power source as described above. The plurality ofelectrodes includes at least one, but preferably a plurality of cathodicelectrodes and at least one, but preferably a plurality of anodicelectrodes. The electrodes may be positioned in a spaced arrangementabout, and preferably conductive through, the exterior of the treatmentapparatus by a conductive material. The electrodes may be arranged in analternating cathodic/anodic fashion about the device. The method furthercomprises the step of providing such device to a non-human animal,thereby allowing delivery of electrical current from the power source,through the electrodes and to at least one of the animal's oralsecretions (e.g., saliva) and oral tissue (e.g., lingual tissue, dentaltissue, gingival tissue, periodontal tissue, and oral mucosa tissue).

The foregoing is considered as illustrative only of the principles ofthe invention. Furthermore, since numerous modifications and changeswill readily occur to those skilled in the art, it is not desired tolimit the invention to the exact construction and operation shown anddescribed. While the preferred embodiment has been described, thedetails may be changed without departing from the invention, which isdefined by the claims.

We claim:
 1. A method for promoting oral hygiene comprising the stepsof: providing a treatment apparatus comprising an electrical powersource and a plurality of electrically conductive surfaces on anexternal surface of the apparatus; making the treatment apparatusaccessible to a non-human animal to be drawn at least partially into themouth of the non-human animal causing conduction of electrical currentbetween the plurality of electrically conductive surfaces; activatingthe treatment apparatus by operating an on/off switch, wherein theon/off switch comprises a motion-activated switch.
 2. A method accordingto claim 1, wherein the motion-activated switch comprises a reed switch.